Waiver of Documentation

Description

Potential participants, or the parents of children who are participants, are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the process (signing of the consent form) has been waived by the IRB.

Situations When It Is Used

This process is often used in minimal risk research involving the administration of online or mailed surveys, telephone interviews, or when anonymous sensitive information is collected and you do not want any written documentation that links the participant to the research study.

Conditions For Approval

The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all participants if it finds either:

That the only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant will be asked whether or not he or she wants documentation linking him or her with the research. The participant's wishes will govern.(NOTE: The FDA has not adopted this category so it cannot be used if the research is subject to the FDA regulations at 21 CFR 50.)

That the research presents no more than minimal risk of harm to participants (i.e., the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests) and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide participants with a written statement regarding the research.

This means that when applying for a waiver of documentation of consent, you will also have to request a waiver or alteration of HIPAA Authorization. The IRB can grant the waiver of alteration if it determines the following criteria are met:

Use or disclosure involves no more than minimal risk to the privacy of individuals because of the presence of at least the following elements:

An adequate plan to protect health information identifiers from improper use or disclosure,

An adequate plan to destroy identifiers at the earliest opportunity absent a health or research justification or legal requirement to retain them, and

Adequate written assurances that the PHI will not be used or disclosed to a third party except as required by law, for authorized oversight of the research study, or for other research uses and disclosures permitted by the Privacy Rule;

Research could not practicably be conducted without the waiver or alteration; and

Research could not practicably be conducted without access to and use of PHI.